PDF(Pubmed)
Abstract：
To perform optimal monitoring of the safety profile in the postmarketing phase, Marketing Authorization Holders and National Regulatory Authorities (NRAs) must evaluate the adverse drug reactions (ADRs) that occurred and characterize their nature, frequency, and severity. Management is possible through Individual Case Safety Reports (ICSRs), which are the reports of organized and processed data. Globally, the International Council for Harmonisation (ICH) E2B guideline suggests harmonized activities for the ICSR electronic content and transmission. In America, the Pan American Health Organization (PAHO) is the agency responsible to implement cooperation among its members, which are recognized as National Regulatory Authorities of Reference (NRARs) such as Argentina, Brazil, Canada, Chile, Colombia, Cuba, Mexico, and the United States. PAHO published the \'Good Pharmacovigilance Practices for the Americas\' suggesting improvement and harmonization in the region. After reviewing the regulatory framework, it is assumed that all NRARs have a regulated ICSR transmission system (i.e. a systematic vigilance system for collecting, analyzing, and disseminating information from ADRs). However, significant differences exist, such as the requirement for social media vigilance, expedited and non-expedited ICSRs, coding, severity, and transmission. The volume of ICSRs has significantly increased, due to using electronic standards managed by the NRAs, which facilitates early identification of new ADRs, allowing the implementation of novel minimization activities, contributing to the continuous assessment of the benefit-risk balance of medicines. Nevertheless, there is still area for improvement, especially in Latin America.
Transmission of spontaneous adverse drug reactions by industry in countries designated as a reference by the Pan American Health Organization (PAHO): comparison on regulatory requirements This review aims to describe regulatory criteria and compare harmonization across regions that marketing authorization holders must fulfill when transmitting spontaneous adverse drug reactions to the authorities for postmarketing surveillance. It centers on the regulatory requirements of authorities designated as a reference by the PAHO. Consequently, it is important to review the regulatory framework, to evaluate the requirements for transmission and have the context of the current harmonization among these agencies in America. This review contains the minimum criteria for transmission and harmonized guidelines according to the International Council for Harmonisation (ICH) and PAHO. However, identifying the differences is only the first step, future research in harmonization must continue to advance the understanding and establish guidelines that allow a better evaluation of the safety profile of medical products.
Transmission of spontaneous adverse drug reactions by industry in countries designated as a reference by the Pan American Health Organization (PAHO): comparison on regulatory requirements This review aims to describe regulatory criteria and compare harmonization across regions that marketing authorization holders must fulfill when transmitting spontaneous adverse drug reactions to the authorities for postmarketing surveillance. It centers on the regulatory requirements of authorities designated as a reference by the PAHO. Consequently, it is important to review the regulatory framework, to evaluate the requirements for transmission and have the context of the current harmonization among these agencies in America. This review contains the minimum criteria for transmission and harmonized guidelines according to the International Council for Harmonisation (ICH) and PAHO. However, identifying the differences is only the first step, future research in harmonization must continue to advance the understanding and establish guidelines that allow a better evaluation of the safety profile of medical products.
摘要：
为了在上市后阶段对安全性进行最佳监控，营销授权持有人和国家监管机构（NRA）必须评估发生的药物不良反应（ADR）并描述其性质，频率,和严重性。可通过个例安全报告(ICSR)进行管理,它们是有组织和处理过的数据的报告。全球范围内,国际协调理事会（ICH）E2B指南建议ICSR电子内容和传输的协调活动。在美国,泛美卫生组织（泛美卫生组织）是负责实施其成员之间合作的机构，被公认为阿根廷等国家参考监管机构(NRAR)，巴西,加拿大,智利,哥伦比亚,古巴,墨西哥,和美国。泛美卫生组织发表了“美洲良好的药物警戒规范”，建议在该地区进行改进和协调。在审查监管框架后，假设所有NRAR都有一个受监管的ICSR传输系统(即收集的系统警戒系统，分析,和传播来自ADR的信息)。然而,存在显著差异，例如对社交媒体警惕的要求，加急和非加急ICSRs，编码,严重程度,和传输。ICSR的数量显著增加，由于使用由NRA管理的电子标准，这有助于早期识别新的ADR，允许实施新颖的最小化活动，有助于持续评估药物的利弊平衡。然而，还有改进的地方，尤其是在拉丁美洲。
在泛美卫生组织（PAHO）指定为参考的国家中，行业对自发性药物不良反应的传播：监管要求的比较本评论旨在描述监管标准，并比较营销授权持有人在将自发性药物不良反应传播给当局进行上市后监测时必须实现的跨区域协调。它以泛美卫生组织指定为参考机构的监管要求为中心。因此,检讨规管架构很重要,评估传输的要求，并了解美国这些机构之间目前的协调情况。根据国际协调理事会（ICH）和泛美卫生组织，本审查包含传输的最低标准和协调准则。然而,识别差异只是第一步，未来的协调研究必须继续增进理解，并建立指南，以便更好地评估医疗产品的安全性。
在泛美卫生组织（PAHO）指定为参考的国家中，行业对自发性药物不良反应的传播：监管要求的比较本评论旨在描述监管标准，并比较营销授权持有人在将自发性药物不良反应传播给当局进行上市后监测时必须实现的跨区域协调。它以泛美卫生组织指定为参考机构的监管要求为中心。因此,检讨规管架构很重要,评估传输的要求，并了解美国这些机构之间目前的协调情况。根据国际协调理事会（ICH）和泛美卫生组织，本审查包含传输的最低标准和协调准则。然而,识别差异只是第一步，未来的协调研究必须继续增进理解，并建立指南，以便更好地评估医疗产品的安全性。
